Generic Name: nilotinib (nye LOE ti nib)Brand Names: Tasigna
Nilotinib interferes with the growth of some cancer cells.
Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).
Nilotinib is usually given to people who cannot take certain other leukemia medications, or who have tried other medications without successful treatment.
Nilotinib may also be used for other purposes not listed in this medication guide.
Before using nilotinib, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, or a family history of "Long QT syndrome." Tell your doctor about all other medications you use.Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after a meal.
Call your doctor at once if you have any serious side effects, such as dizziness, fainting, fast or pounding heartbeat, feeling short of breath, swelling, seizure, warmth, redness, or tingly feeling under your skin, jaundice (yellowing of the skin or eyes), or severe pain in your upper stomach spreading to your back, with nausea and vomiting.There are many other medicines that can cause interact with nilotinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
To be sure this medication is not causing harmful effects, your blood and bone marrow will need to be tested on a regular basis. Your heart rate may also be checked using electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Do not miss any scheduled appointments.
low blood levels of potassium or magnesium; or
a history of "Long QT syndrome."
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
heart disease or heart rhythm disorder;
a personal history of pancreatitis; or
a family history of "Long QT syndrome."
Nilotinib capsules may contain lactose. Talk to your doctor before using this medication if you have galactose intolerance, or severe problems with lactose (milk sugar).
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medicine with a large glass of water. Do not break or open a nilotinib capsule. Swallow the pill whole.
Nilotinib is usually taken every 12 hours.
To be sure this medication is not causing harmful effects, your blood and bone marrow will need to be tested on a regular basis. Your heart rate may also be checked using electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Do not miss any scheduled appointments.Do not stop using nilotinib or change your dose without talking to your doctor. If you stop taking the medication too soon, your condition may get worse. Store nilotinib at room temperature away from moisture and heat.
See also: Nilotinib dosage in more detail
Skip the missed dose and take your next dose at the regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include severe muscle cramps.
Grapefruit and grapefruit juice may interact with nilotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
dizziness and fast or pounding heartbeat;
shortness of breath;
swelling in your hands or feet;
warmth, redness, or tingly feeling under your skin;
nausea, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe pain in your upper stomach spreading to your back; or
dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, muscle pain or weakness, uneven heart rate, or feeling like you might pass out.
Less serious side effects may be more likely to occur, such as:
skin rash or itching;
headache, spinning sensation;
numbness or tingling;
sleep problems (insomnia);
joint or muscle pain; or
runny or stuffy nose, cough, sore throat, hoarseness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Chronic Myelogenous Leukemia:
For use in the treatment of patients with chronic phase or accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) resistant to or intolerant to prior therapy that included imatinib:Initial dose: 400 mg orally twice daily, approximately 12 hours apartTreatment should continue as long as the patient does not show evidence of progression or unacceptable toxicity.
Before taking nilotinib, tell your doctor if you are using any of the following drugs:
arsenic trioxide (Trisenox);
chloroquine (Arelan) or halofantrine (Halfan);
isoniazid (for treating tuberculosis);
a blood thinner such as warfarin;
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Invirase);
narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose);
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifadin, Rifamate, Rimactane), or telithromycin (Ketek);
an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
an antidepressant such as amitriptyline (Elavil, Etrafon), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), and others;
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace).
This list is not complete and there may be other drugs that can interact with nilotinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.